By Ed Emerson
To prevent infection, a device’s packaging or “sterile barrier system” must maintain sterility over the product’s entire shelf-life. In fact, packaging can be the weak link in the chain of steps designed to keep a product sterile from production to final use.
In its guidance, the FDA lists four advantages of container and closure system integrity tests.
- the ability to “detect a breach...prior to product contamination”
- the ability to “conserve samples that may be used for other stability tests”
- the fact that they “require less time than sterility test methods”
- the fact that “the potential for false positive results may be reduced”
But integrity testing offers other benefits as well. Like traditional microbial challenge testing, it can be used during package development for periodic checks on production or when critical events occur. Unlike microbial challenge, however, integrity testing doesn’t incur the delay required for culturing, making it far more convenient and usable. Nor does it require highly trained specialists or incur the same risk of operator error.
Ease of testing means packages can be tested more often over their anticipated lifecycle. This can be critical for packaging that is shipped, handled, and otherwise challenged in ways that may affect its ability to keep contents sterile. Package integrity testing using instrument methods can be more sensitive, repeatable, and reproducible and, therefore, more reliable. Depending on package design, a variety of package integrity testing methods may be employed.